Management of meniscal injuries of the knee

                       Management of meniscal injuries of the knee

                                              Dr KS Dhillon FRCS

Introduction

The role played by the menisci in function of the knee has been well established. It is important to preserve the meniscus whenever possible. Degenerative tears of the meniscus are common and can be present in asymptomatic individual. Arthroscopic partial meniscectomy is and has been one of the most common orthopaedic surgical procedure in most countries around the world. However, there is now good evidence available to show that arthroscopic partial meniscectomy does not benefit most patients with meniscal tears. This article reviews the recent literature and attempts to settles some of the controversies associated with the management of meniscal injuries of the knee.

Anatomy of the meniscus

The are two menisci in the knee, namely the medial and lateral meniscus. The medial meniscus is C-shaped with a triangular cross section. The average width is about 9 to 10 mm and the average thickness is about 3 to 5 mm. The lateral meniscus is almost circular in shape and it covers a large portion of the articular cartilage. Its average width is 10 to 12 mm and its average thickness is about 4 to 5 mm.
The menisci are composed of fibroelastic cartilage. The fibroelastic cartilage is made of an interlacing network of collagen, proteoglycan, glycoproteins, cellular elements and 65-75% water. Ninety percent of the collagen is type I collagen. There are two types of fibres, the longitudinal
(circumferential) and the radial fibres, which allow the meniscus to expand under compressive load, expand the contact area and reduce stresses across the the joint.
The medial inferior genicular artery supplies the peripheral 20-30% of medial meniscus and the lateral inferior genicular artery supplies peripheral 10-25% of lateral meniscus. The central 75% of both menisci receive nutrition through diffusion.

Classification of meniscus tears

A.Descriptive classification of meniscal tear by location

Meniscal tears can occur in the red zone (outer third, vascularized), in the
red-white zone (middle third) or in the white zone (inner third, avascular).

 B.Descriptive classification of meniscal tear by pattern of tear

Meniscal tears can be classified into three types based on the pattern of tear [1]:

1.Basic tears
   A.Longitudinally oriented tears
       i.Horizontal tears (cleavage tears)--These tears are parallel to the    tibial plateau involving one of the articular surfaces or free edge and they divide the meniscus into superior and inferior parts.
        ii. longitudinal tear (vertical tear)--The tear is perpendicular to the tibial plateau and parallel to the long axis of the meniscus. It divides the
divides the meniscus into medial and lateral parts. A Wrisberg rip is a specific subtype, longitudinal tear in the posterior horn of the lateral meniscus that extends laterally from the Wrisberg ligament attachment.
  B.Radial tears -- These tears are perpendicular to both the tibial plateau and the long axis of the meniscus.
  C.Root tears: These tears are typically radial-type tear located at the root of the meniscus.

2.Complex tears
These tears are a combination of all or some of the horizontal, longitudinal and radial-type tears.

3.Displaced tears
Displaced tears are those in which the torn portion of the meniscus is displaced and it can still be attached to the  parent meniscus or detached. There are 3 subtype of displaced tears.
Flap tear: displaced horizontal or longitudinal tears
Bucket-handle tear: displaced longitudinal tear
Parrot beak tear: displaced radial tear

Radiological diagnosis

An MRI has a sensitivity of about 95% and a specificity of 81% for medial meniscal tears and a sensitivity of about 85% and a specificity of 93% for lateral meniscal tears [2]. An MRI of the knee is the modality of choice for investigating a suspected tear of the meniscus and sagittal images are  most useful [3]. A MRI of the knee has an overall 88% sensitivity and 94% specificity for detecting meniscal lesions [4].
There are three MRI criteria for diagnosis of meniscal tears [3]:
A high intrameniscal signal extending to at least one articular surface
The high intrameniscal signal should be seen in at least two slices  (two slice touch rule).
Distortion of the normal meniscal morphology if there has been no prior surgery.
In the T1 sequence a hyperintense line in the meniscus can be due to a tear or due to degeneration. When there is a bucket handle tear an empty groove may be seen.
In the T2 sequence the hyperintense line in the meniscus which indicates synovial fluid in the meniscus may be due to degeneration and not a tear in an adult and due to high vascularity in children [5].
MRI grading system for meniscal signal intensity [6].
The MRI abnormal high meniscal signal intensity can be graded into three:
Grade 1: There is a small focal area of hyperintensity with no extension to the articular surface
Grade 2: There is a linear area of hyperintensity with no extension to the articular surface
2a: There is a linear abnormal hyperintensity with no extension to the articular surface
2b: There is an abnormal hyperintensity which reaches the articular surface on only one single image
2c: There is a globular wedge-shaped abnormal hyperintensity with no extension to the articular surface
Half of the patients with grade 2c abnormal meniscal signals have been found to have meniscal tears on arthroscopy [7]
Grade 3: There is abnormal hyperintensity which extends to at least one articular surface (superior or inferior) which is indicative of a definite tear of the meniscus

A grade 3 MRI signal is indicative of a tear of the meniscus and a "double anterior horn" sign and a "double PCL"  sign are both indicative of a bucket handle tear of the meniscus.

Prevalence of meniscal abnormalities on MRI of the knee

Zanetti et al (8] studied 100 patients with suspected meniscal tears, who had one symptomatic knee and the other asymptomatic knee, with an MRI of the knee to evaluate the prevalence of meniscal abnormalities in the knee. The mean age of these 100 patients was 42.7 years with a range between 18 to 73 years.
They found meniscal tears in 57 symptomatic knees (57%) and in 36 contralateral asymptomatic knees (36%). In the 57 patients who had a tear of the meniscus on the symptomatic side, 63% of these patients had a tear in the contralateral asymptomatic side. In other words, if there is a tear of the meniscus on the symptomatic side, there is a 63% chance that there will be a tear on the opposite asymptomatic side.
Radial, vertical, complex, or displaced meniscal tears and abnormalities of the collateral ligaments, pericapsular soft tissues, and bone marrow abnormalities were mostly seen in symptomatic knees and these findings appear to be clinical significant. Horizontal or oblique meniscal tears on the other hand were frequently seen in both asymptomatic and symptomatic knees and these findings may not often be related to symptoms [8].
Englund et al [9] studied the prevalence of meniscal damage in the general population and the association of meniscal tears with knee symptoms and with radiographic evidence of osteoarthritis. They found that the prevalence of a meniscal tear or of meniscal damage in the right knee as seen on a MRI ranged from 19% (range 15 to 24), among women 50 to 59 years of age, to 56% (range 46 to 66) among men 70 to 90 years of age. Among individuals with radiographic evidence of osteoarthritis (Kellgren–Lawrence grade 2 or higher) the prevalence of a meniscal tear was 63% among those with knee symptoms on most days and 60% among those without symptoms. The corresponding prevalence of meniscal tears among persons without radiographic osteoarthritis were 32% and 23%. Sixty-one percent of the individuals who had meniscal tears in their knees had no symptoms during the previous month.
The authors concluded that incidental findings of meniscal abnormalities on MRI of the knee are common in the general population and increases with age, irrespective of knee symptoms, and often accompanies knee osteoarthritis. Hence clinicians who order MRI of the knee should keep in mind the high prevalence of incidental tears when interpreting the MRI and  planning therapy.
Other authors have reported a high prevalence of meniscal damage ranging from 67 to 91% in patients with symptomatic osteoarthritis of the knee [10,11,12,13].
In the study by Bhattacharyya et al [13], which involved U.S. veterans,  most of whom were men, meniscal tears were noted in 75.5% control subjects who had no knee pain (mean age, 67 years) and had sought medical care for other conditions. They also found that knees with meniscal tear were not more painful than those without a tear and that meniscal tears do not affect functional status in patients with knee OA.
Other studies have also showed that a meniscal tear of the knee is common in individuals who had no symptoms of the knee [14,15,16,17,18].

Treatment of meniscal tears

There are three treatment options for patients with symptomatic tears of the meniscus. These include non-operative treatment, meniscectomy and meniscal repair. Selecting appropriate treatment can often be difficult and will depend on the patient characteristics such as age, co-morbidities and tear characteristics such as the type, location and size of tear.
Non-operative treatment of meniscal tears
There is level I irrefutable evidence that patients with osteoarthritis of the knee with meniscal tears do not benefit from arthroscopic debridement of the joint. Hence the treatment of choice for degenerative meniscus tears is non-surgical.
Moseley et al (19) did a randomised, placebo-controlled trial to assess the efficacy of arthroscopic knee surgery to relieve knee pain and improve function in patients with OA of the knee. They had three groups of patients who either had, joint lavage, joint debridement or sham incisions at the arthroscopic portals. Their study showed strong evidence that arthroscopic lavage with or without debridement is no better than placebo in relieving pain and improving self-reported knee function.
Kirkley et al (20) in 2008 published the outcome of a single-center, randomized, controlled trial of arthroscopic surgery in patients with moderate-to-severe osteoarthritis of the knee. They randomly assigned patients to arthroscopic joint debridement with surgical lavage and  physical plus  medical therapy or to treatment with physical and medical therapy alone. At 2 years follow up they found that arthroscopic surgery for osteoarthritis of the knee provided  no additional benefit as compared to optimized physical and medical therapy.
Sihvonen et al (21) did a multicenter, randomized, double-blind, sham-controlled trial to assess the efficacy of arthroscopic partial meniscectomy in patients who had a degenerative tear of the medial meniscus without knee osteoarthritis. Patients with obvious traumatic onset of symptoms and those with OA were excluded. The study showed that arthroscopic partial meniscectomy was not superior to sham surgery, with regard to pain and functional knee scores assessed during a 12-month follow-up period. The authors concluded that partial meniscectomy for degenerative tears provides no benefit to the patients and that there is no scientific basis for continuing the current practice of doing partial meniscectomy for degenerative tears of the meniscus.
Thorlund et al [22] did a comparative prospective cohort study, to compare patient reported outcomes, of arthroscopic partial meniscectomy in patients with traumatic meniscal tears as compared to that in patients with degenerative meniscal tears, at 52 weeks follow up.
They studied four of five subscales of the knee injury and osteoarthritis outcome score (KOOS) which covered pain, symptoms, sport and recreational function, and quality of life (KOOS4). Their study showed
better self-reported outcomes in patients with degenerative tears as compared to patients with traumatic tears but the difference between the two groups ‘was at no time point considered clinically meaningful’ [22].
The authors questioned the ‘current tenet that patients with traumatic meniscal tears experience greater improvements in patient reported outcomes after arthroscopic partial meniscectomy than patients with degenerative tears’ [22].
So far there have been no randomised controlled trials comparing the outcome of arthroscopic partial meniscectomy with sham surgery or non-surgical treatment for traumatic meniscal tears [23].
Sihvonen et al’s  study (21) provides level I evidence that arthroscopic partial meniscectomy in patients with degenerative tear of the meniscus provides no benefit to the patient when compared with a sham operation. Thorlund et al’s [22] comparative prospective cohort study shows that the outcome of arthroscopic partial meniscectomy in patients with traumatic meniscal tears is no better than that of partial meniscectomy in patients with degenerative tear of the meniscus. This would mean that arthroscopic partial meniscectomy has no role to play in the treatment of partial tears of the meniscus.
Non-operative treatments such as exercise and quadricep strengthening improves knee function and reduces knee pain [24,25,26]. Pain and swelling associated with meniscal tears can be treated non-steroidal medications.
There is definitely no role for surgery in the treatment of degenerative tears of the meniscus. The outcome of partial meniscectomy for traumatic tears of the meniscus is not better than that of partial meniscectomy for degenerative tears as has been believed in the past.

Surgical treatment of traumatic tears of the meniscus

The role played by the menisci in function of the knee has been well established. The main function includes load bearing, shock absorption, stabilisation, joint lubrication, nutrition of the articular cartilage and proprioception [27]. Hence in the management of patients with traumatic meniscal tears all attempts to preserve the meniscus are made.
Pain and mechanical symptoms such as clicking, catching, locking, pinching, or a sensation of giving way associated with unstable meniscal fragment may need surgical intervention.
Unstable meniscal fragments not amenable to repair have to be excised by arthroscopic partial meniscectomy. Tears in the red-red zone, where there is blood supply, can be repaired because there is potential for healing. Some in the red-white zone can heal when repaired. Tears in the rest of the meniscus which is avascular, cannot be repaired, are subjected to a meniscectomy.
Studies comparing the outcome of meniscal repair with meniscectomy are limited. It is difficult to postoperatively define a healed meniscus because postoperative MRIs are not very accurate in defining a successful repair. High signal seen on an MRI may represent oedema, degeneration of the meniscus, an actual tear or postoperative healing and scar [28]. The most accurate way to access a successful repair would be a second look arthroscopy but there can be ethical concerns when second-look arthroscopies are performed to evaluate the success of a meniscal repair. Randomising patients to receive a repair or a meniscectomy can also lead to ethical concern[29].
Seo et al [30] did a second look arthroscopy in 11 patients (who were available for review) out of 21 consecutive patients who underwent arthroscopic pullout suture repair for a posterior root tear of the medial meniscus, at an average of 13.4 months (range 10 to 22 months) follow up. In this case series (level 4 evidence), they found that in none of the patients a complete healing had occurred.
In 5 knees there was lax healing, 2 of which were symptomatic and three asymptomatic. In 4 knees there was scar tissue healing and all 4 were asymptomatic. In  2 knees there was no healing and of the 2, one was symptomatic and one asymptomatic. There was progression of the chondral lesion in one case. The mean Lysholm scores improved from 56.1 preoperatively to 83.0 at follow-up and the mean Hospital for Special Surgery score also significantly increased, from 64.1 to 87.4.
Despite the lack of complete healing in all patients,why there was significant clinical improvement remains unexplained.
Cho et al [31] retrospectively reviewed 13 of 20 consecutive patients who underwent arthroscopic modified pull-out suture repair for a posterior root tear of the medial meniscus. The 13 were available for a second-look arthroscopic evaluation. In 4 cases there was complete healing , in 4 lax healing, in 4 scar tissue healing and in 1 there was no healing. Seven of the 13 patients were asymptomatic. The mean Lysholm scores increased from 34.7 points before the repair to 75.6 points at the second-look arthroscopy and the HSS scores increased from 33.5 to 82. Functional outcome was good in these patients despite incomplete healing of the repair.
Pujol et al [32] evaluated healing of the meniscus after a repair using arthro-CT scans. At 6 months post repair of the meniscus an arthro-CT scan showed complete healing in 58% of the patients, partial healing in 24% and failed healing in 18% of the patients. They also found that the healing in posterior segment tears was lower than that in middle portion tears. Despite the the lack of complete healing in almost half of the patients, the clinical outcome was good in most of the patients.
Paxton et al [33] did a systematic literature review to compare reoperation rates and clinical outcomes after meniscal repair and partial meniscectomy in patients with traumatic meniscal tears. At short and long term follow up partial meniscectomy had lower reoperation rates. The short and long term reoperation rates for partial meniscectomy were 1.4% and 3.9% respectively whereas for meniscal repair were 16.5% and 20.7% respectively. There were a limited number of studies with long term clinical outcome and these small number of studies reported that a meniscal repair was associated with higher Lysholm scores and less radiologic degeneration than partial meniscectomy.
Noyes and Barber-Westin [34] did a systematic review of the literature in 2012 to find out the incidence of meniscectomy, meniscus repair, and tears left in situ during ACL reconstruction in the previous 10 years. In the 159 studies analysed, there were 11,711 meniscal tears. Sixty-five percent of the tears were treated by meniscectomy, 26% of the tears were repaired and 9% were left in situ without any treatment. The incidence of meniscal repair was 26% in patients undergoing ACL reconstruction.
Mutsaerts et al [35] in 2016 did a literature review of all randomized controlled clinical trials which compared various surgical techniques for the treatment of meniscal injuries including; total and partial meniscectomy; meniscectomy and meniscal repair; meniscectomy and meniscal transplantation; open and arthroscopic meniscectomy and various different repair techniques.
This Level I meta-analysis showed that there is a lack of level I evidence to guide the surgical management of meniscal tears.
Degenerative tears of the meniscus do not need any surgery and most traumatic tears of the meniscus also do not need surgery. Patients with traumatic tears who have mechanical symptoms may need surgery. Tears in the avascular region would need a partial meniscectomy. Whether to do a meniscal repair or not remains unclear since there is a lack of level I evidence to guide treatment options. There have been case reports where spontaneous healing of bucket handle tears of the meniscus have occurred, when patients have opted for non-operative treatment or surgery has been delayed for some reason [35,36,37]. Furthermore, definitely there are patients who sustain meniscal injuries and never seek treatment, where spontaneous healing occurs.

Complications of arthroscopic surgery

The overall complications for knee arthroscopy are about 8.2% [38]. Sherman et al [38] retrospectively reviewed 2640 arthroscopic procedures and found an 8.2% incidence of complications,of which 4.8% were major and 3.6% minor complications.The major complications included infections, hemarthrosis, adhesions, effusions, cardiovascular, neurological, reflex sympathetic dystrophy, and instrument breakage, and the minor complications included problems with wound-healing and ecchymosis. Diagnostic arthroscopy had the lowest complication rate and partial medial meniscectomy was associated with a higher complication rate and highest hemarthrosis rate, while partial lateral meniscectomy was associated with the highest rate of instrument breakages. Age more than 50 years and a tourniquet time of more than 60 minutes were risk factors for complications. Surgeon experience had no influence on the complication rates [38].
Salzler et al [39] found a 2.8% complication rate for meniscectomy and a 7.6% complication rate for meniscal repair. They found that the complication rates were higher with sports fellowship-trained surgeons as compared to those who had no sports fellowship training.
Austin and Sherman [40] in a study involving 101 consecutive arthroscopic meniscal repairs found an overall complication rate of 18%. In patient with anterior cruciate tears the meniscus repair was associated with a 20% risk of complication and in those without anterior cruciate injury the complication rate was 14%. The incidence of arthrofibrosis was 10% when there was an ACL tear and 6% when there was no ACL tear in patients undergoing meniscal repair. The overall risk of complications was 19% with medial meniscus repair and 13% with lateral meniscus repairs. The reoperation or rehospitalization rate (excluding repair failures) was 8%.

Infection
Septic knee arthritis following simple arthroscopy procedures is uncommon but it is dreaded complication. The incidence of septic arthritis following simple arthroscopic procedures ranges from 0.009% to 1.1% [41].
In this study the most common pathogen causing infection was Staphylococcus , both coagulase positive and negative. Other bacterias implicated included Enterobacter cloacae, Streptococcus spp. and Serratia marcescens [41].
Risk factors for septic arthritis include age more than 50 years, tourniquet time more than 60 min, longer duration of surgery, male sex, diabetes, morbid obesity, tobacco use, use of intra-articular steroids and complex procedures [41].

Thromboembolic complications
Venographic incidence of deep-vein thrombosis (DVT) after arthroscopy can be up to 17.9% [42]. Most of these are distal and of not much clinical significance.
The incidence of symptomatic and proximal thromboembolic disease,
which can progress to pulmonary embolism (PE), is less than 1% in patients undergoing knee arthroscopy [43-47]. Routine thromboprophylaxis is not recommended for patients undergoing arthroscopy unless certain risk factors such as older age, history of cancer, complexity of surgery, female sex, longer duration of surgery, history of previous DVT, obesity, immobility, varicose veins and use of oral contraceptives, are present [48,49]. A postoperative high index of suspicion is essential in patients where these risk factors are present.

Vascular complications
The Committee on Complications of the Arthroscopy Association of North
America, reported 12 vascular injuries (0.0032 %) in 375,069 knee arthroscopies carried out in North America. Out of these 12 cases of vascular injury reported, 4 required an amputation [50]. DeLee [51], in the
AANA review of complication of arthroscopy in the US, reported six cases of penetrating injury to the popliteal artery (0.005%) in 118,590 arthroscopic procedures. In 4 of these 6 patients an amputation was required.
Although the incidence of vascular injury is low in patients undergoing arthroscopy, a high index of suspicion is necessary and a prompt diagnosis, and early surgical intervention is essential to prevent a risk of loss of limb or life.

Neurological injury
Rodeo et al [52] reported that there are 4 mechanisms by which nerve injury can occur during arthroscopy.These include, direct trauma, pressure
secondary to a compartment syndrome occurring as a result of extravasation of fluid, damage related to the use of a tourniquet and due to reflex sympathetic dystrophy. The reported incidence of neurological injury following knee arthroscopy ranges between 0.01 to 0.6 percent [51]. The nerves that can be injured include the saphenous, tibial and peroneal nerves. The most commonly injured nerve is the saphenous nerve followed by the peroneal nerve. Neurological complications are more often seen with meniscus repairs.

Conclusions

A clinical diagnosis of meniscus tear should be made when a patients complains of knee pain following trauma to the knee. A history of mechanical symptoms of catching, click and giving way would suggest the presence of an unstable meniscus tear which would require treatment. All other tears of the meniscus do not need treatment and hence there is no need for radiological investigations. When clinical diagnosis of an unstable tear of the meniscus which requires surgery is made, an MRI of the knee would be a useful investigation. There is no role of arthroscopic meniscectomy in the treatment of degenerative and traumatic tears when the tear is stable.
There is, however, a lack of Level I evidence to guide the surgical management of traumatic meniscal tears. Studies comparing the outcome of meniscal repair with meniscectomy are limited and of not good quality. Arthroscopy and meniscal surgery can be associated serious complication although the incidence of serious complications is low.




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Legal Issues Surrounding Electronic Medical Records

                 Legal Issues Surrounding Electronic Medical Records

                                                  Dr KS Dhillon LLM

What is electronic medical record (EMR)?

Traditionally medical records have been paper based. The hospitals have been collecting handwritten patient medical data and storing it securely as per the legal requirement of handling and storing patients confidential medical data.
Over the last couple of decades there has been a push to record, process, store and transfer health information electronically. This electronically recorded, processed and stored medical data is known as electronic medical records (EMRs). The electronic application not only helps in recording clinical data, X-rays and laboratory findings but also helps in making decisions, making request for medication from the pharmacy and placing and receiving orders regarding patient care [1]. The EMR system would require the use of a computer system with the necessary software along with a network.
The touted benefits of the EMR include improvement in quality of patient care, decrease in health care costs, reduction in storage space requirements and easy of searching the patients records. Electronic data can be more easily retrieved and modified and updated thereby increasing efficiency. By using appropriate templates the doctors can safe time and make less mistakes [1].
Some believe that these electronic systems which are faster than the paper system can save time, lives, and money [1].
Despite the touted benefits of the EMR the transition from paper to electronic recording has been very slow. In the USA the Healthcare Information and Management Systems Society (HIMSS) has planned the implementation and use of the EMR system in 7 stages. As of 2013 EMR implementation was in stage 2 and stage 3. In stage 6, about 100 % of the hospitals were expected to be covered. Stage 7, would see the building of the regional and national network that would integrate all the EMR systems in the country [1]. In the US as of 2013 only 25.5% of the hospitals had a comprehensive EMR.
In Malaysia, the Ministry of Health, in 2001 claimed that Hospital Selayang was the first hospital in the world to have a comprehensive ICT paperless system using the Total Hospital Information System (THIS)[2].
The capital cost of equipping a hospital with THIS is about 80 to 100 million ringgit in Malaysia and this constitutes almost 40% of the total development cost of a 800-1000 beds hospital. So far the Malaysian government has spent more than 600 million Ringgit for the project and this does not
include operation and maintenance cost of the system [2]. As of 2015 only 21 out of 138 public hospitals (15%) had implemented either the Total Hospital Information System (THIS), the Intermediate Hospital Information System (IHIS) or Basic Hospital Information System (BHIS).
Though firewalls and encryption do permit safer and secure transfer of health information, confidentiality of patient information and other legal risks remains a concern.

Legal Risks of EMRs

The legal system relies on precedent and is slow to adopt new technologies such as EMRs. Hence it can offer little help in the navigation from paper-based to electronic record [3]. Though EMRs may be able to solve problems of missing clinical information that was seen with paper records, there is no legal precedent addressing the responsibility of clinicians reviewing the large amount of clinical information available in the integrated EMRS. Many find it difficult to review the complete electronic record within a reasonable timeframe [3].
Furthermore EMRs introduce several more liabilities. Large amounts of perfectly legible data can be stored in EMRs which makes it easily discoverable, unlike incomplete or illegible handwritten records which are not easily discoverable. Hence the EMR data can be a liability to the doctor and the health provider.
EMRs can store extremely huge amount of data which can lead to information overload resulting in the doctor overlooking key information in the system. This again can be a new form of liability. In this mountain of information, doctors can miss critical information which can affect treatment decision which would make doctors and the hospital liable for negligence [3].
With EMRs the doctors legal responsibility and accountability increases. The electronic records will identify the person who reviewed or failed to review key information such abnormal findings recorded in the EMR. Failure to identify and address important abnormal findings can lead to legal challenges. With paper records it is not always possible to tell who accessed the records. Lapses in management of the patient can easily be detected with EMRs[3].
There are some document related issues with EMRs which can introduce new liabilities. Some EMRs contain progress note documentation templates which allow test results to be automatically imported. This automatically imported test and clinical findings may not be within the clinical preview of the the person inadvertently importing the information and signing the note electronically and this may introduce new liabilities [3]. Notes that are copied and pasted may contain lots of information that appear similar and display information that is no longer correct.

Ethical issues with EMRs

Data in EMRs can more easily be accessed by many individuals as compared to data in paper records. Data in paper records can also be accessed by others but it is difficult to track who accessed the paper records. Since more people have access to electronic data the potential for privacy breach increases. When many people have access to electronic data the question of ownership of data also arises. Who actually owns this protected health information?[3]
In the past ‘several electronic health records (EHR) vendors (eg, Cerner, GE, and Allscripts [formerly Eclipsys]) have sold deidentified copies of their patient databases to pharmaceutical companies, medical device makers, and health services researchers’ [3]. Although the data is deidentified, it is not difficult to reidentified the data using publically available external data sources[3].
There are EHR user guidelines but what happens when unauthorized personnel access the the data and also what happens when unintentional or unavoidable violation of the guidelines take place? An example would be when a person who is logged in has to rush off for an emergency and someone standing by accesses the data. These situations raise complex ethical and legal issues[3].
This electronic data-driven approach in medicine has a long way to go. There are many unaddressed issues to be sorted out. Who will ‘oversee the data aggregation, verification and validation, and analysis; who will have data access; who will make the final data interpretations; and assuming that everyone agrees they are correct, who will adjudicate the ethical disagreements that inevitably surface when data are used to inform new health care policies’ [3]. There is a dire need for ‘nonpartisan, multidisciplinary, expert review-panels composed of clinicians, statisticians, informaticians, ethicists, and patient advocates’ to sit together and address these issues rather than pushing half baked electronic systems done the throat of unwilling users.
The goal of providing higher quality, lower-cost health care through widespread EHR remains elusive.

Risk for medical malpractice claims

Doctors are at an increased risk of medical malpractice claims when the EMR is being implemented and in the initially phase these EMRs can be a thorn in physicians' side.The transition period from a familiar to unfamiliar system introduces risk of error. The impact of the EMRs on the medical malpractice claims, however, is still unclear [4].
When there is malpractice litigation, EMRs can provide clear, complete, organized and legible data and documentation that can prove a malpractice claim. Pre-trial discovery from the EMRs can increase the chances of prosecutors finding some evidence of wrongdoing among an entire team of providers [4].
When there are errors in the accuracy of the clinical content in the EMR or the the manner of presentation of clinical data is poor, the EMR vendor cannot be held liable and the malpractice risk for physician increases. Invariable there will be various limitations related to liability of the EMR vendor in the EMR contract [4]. Another issue that is likely to crop up is, what happens to the old medical records whenever the system is upgraded? Will the complete old records be maintained or only certain screenshots will be maintained due cost constraints.

Likelihood of medical errors

Estimates in the USA show that adverse drug events (ADEs) will injure or kill 770,000 people in hospitals every year [5]. The most common cause of these ADEs is prescribing errors [6]. Computerized physician order entry (CPOE) systems built into the EMRs are expected to reduce prescribing errors and save hundreds of billions in annual costs. However, many believe that too much dependence on an EMR will result in small mistakes quickly turning into medical errors [4].
Koppel et al [7] published a study in 2005 which identified and quantified  the role of CPOE in facilitating prescription error risks. They found that the CPOE systems facilitated 22 different types of medication error risks, which included pharmacy inventory displays being mistaken for ‘dosage guidelines, inflexible ordering formats that generated wrong orders, and CPOE display screens that prevented a coherent view of the patient's medications’[4].  They study also revealed that 75 percent of clinical staff surveyed said that they encountered these error risks weekly or sometimes more often.
Doctors overreliance on functions such as cut and paste can perpetuate mistakes while leaving a trail of errors which are less likely to be discovered and corrected [8]. The cut and paste function also raises issues regarding ownership of the records when a legal investigation is carried out. There are also issues of risk of bugs, viruses or other technological inefficiencies with EMRs which was not there with paper records [8]. An accidental click of the mouse can be dangerous and harmful in some circumstances.

Breaches, theft and unauthorized access to protected health information

Way back in 1996 the US Congress recognized that advances in electronic technology could erode the privacy of health information and the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, was passed to improve the efficiency and effectiveness of the health care system. HIPAA provisions mandated Federal privacy protections for individually identifiable health information [9]. The Department of Health and Human Safety USA posts all data breaches on a public website. In 2009 there were 2.4 million patients affected by health data breach and in 2010, 5.4 million patients were affected. The most common cause of breaches was theft of patient data. Human error, loss of records and intentional unauthorized access to protected information were the other causes of breaches [4].
The Department of Health & Human Services (HSS) does not take HIPAA violations lightly. In 2011, a computer was stolen from the administrative office of California based Sutter Health which potentially exposed the private data of about 4 million patients. The Department of HHS and the Office for Civil Rights issued a civil money penalty of $4.3 million against Largo, Md.-based Cignet Health for the HIPAA violation. Two days later, HHS and the Office for Civil Rights announced that Massachusetts General Hospital in Boston had agreed to pay $1 million to settle potential HIPAA violations [4].
In Malaysia we have the Personal Data Protection Act 2010 which protects the patients physical and mental health data. Section 9 of the Act (Security Principle) makes the data user responsible for taking practical steps to ‘protect the personal data from any loss, misuse, modification, unauthorized or accidental access or disclosure, alteration or destruction’ [10]. The Act requires protection of the place of storage and the equipment where the data is stored. Measures have to be taken to ensure the reliability, integrity and competence of personnel having access to the personal data; and measures have to be  taken to ensure the secure transfer of the personal data [10].
It is not known if the Personal Data Protection Act 2010 will have the bite of HIPAA or it will remain all bark and no bite as was the case with the HIPAA in its early days.
Hospitals would have to have comprehensive policies and procedures in place and their staff have to be trained to comply with the policies and procedure to prevent breaches, theft and unauthorized access to protected health information. Impermissible use or disclosure of protected patient information should be thoroughly investigated and appropriate remedial action taken. Accurate documentation related to the incident and the investigation should be retained.

What healthcare leaders need to do?

The physicians and other health care workers in the hospital have to be well-informed about compliance and legal risks of the EMRs. The training process is not always easy. Initiatives in EMR education are important to make sure that the doctors and staff do not take legal risks out of ignorance [4].
It can be difficult to train doctors to use the new software because they are usually ‘trained to autonomously practice medicine’ and change is difficult for them. One on one personalised training in a private environment is often most useful and productive. In the one to one environment the doctor can think about and discuss the impact of the software on their workflow [4]. The cooperation between the hospital IT department and the doctors must be enhanced and promoted by the health care leaders.

References

1. PeterChris Okpala.  The Electronic Medical Record (EMR). Journal of Applied Medical Sciences. 2013; 2 (2): 79-85.
2. Roshidi Hassan et al. Implementation of Total Hospital Information System (THIS) In Malaysian Public Hospitals: Challenges and Future Prospects. International Journal of Business and Social Research (IJBSR). 2012;2 (2): 33-41.
3. Perritt HH. Law and the Information Superhighway. 2nd ed. Somerset, NJ: Aspen Publishers; 2009.
4. Molly Gamble. 5 Legal Issues Surrounding Electronic Medical Records. 2012. at https://www.beckershospitalreview.com/legal-regulatory-issues/5-legal-issues-surrounding-electronic-medical-records.html accessed on 28/4/2018.
5. Lesar TS, Lomaestro BM, Pohl H. Medication prescribing errors in a teaching hospital: a 9-year experience.  Arch Intern Med. 1997;157:1569-1576.
6. Leape L, Bates D, Cullen D.  et al.  System analysis of adverse drug events.  JAMA. 1995;274:35-43.
7. Koppel R, Metlay JP, Cohen A, et al. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. JAMA. 2005;293(10):1197–1203. doi:10.1001/jama.293.10.1197.
8. Mangalmurti SS, Murtagh L, Mello MM. Medical Malpractice Liability in the Age of Electronic Health Records. N Engl J Med 2010;363(21) 2060-2067. 
9. HIPAA for Professionals; Health Information Privacy; U.S. Department of Health & Human Services at https://www.hhs.gov/hipaa/for-professionals/index.html accessed on 1/5/2018.
10. LAWS OF MALAYSIA ACT 709, PERSONAL DATA PROTECTION ACT 2010 at http://www.pdp.gov.my/images/LAWS_OF_MALAYSIA_PDPA.pdf accessed on 1/5/2018.