Non-Hospital Owned Medical Equipment Poses Challenge

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					                                                                           ACCREDITATION NEWS & VIEWS

Non-Hospital Owned
Medical Equipment Poses Challenge
Robert Stiefel

          here are a handful of issues that plague clini-        acteristics	of	each	hospital.	How	far	should	a	hospital	go	
          cal engineering departments. More often than           to ensure that all medical equipment receives the right
          not, these issues combine elements of technical        attention?	 Does	 the	 appropriate	 level	 of	 attention	 vary	
operations, customer satisfaction, and regulatory compli-        depending	 on	 the	 type	 of	 equipment	 or	 who	 owns	 it?	
ance. Non-hospital owned medical equipment is one of             How	can	a	clinical	engineering	department	facilitate	the	
these issues.                                                    development and implementation of practices for non-
   Non-hospital owned equipment can come from pa-                hospital	owned	medical	equipment?	Here	are	my	sugges-
tients, vendors, leases, rentals, physicians, or professional    tions for an effective system:
services companies. Patients often want or need to bring            Determine the sources and types of equipment
medical devices with them when they are admitted to              that are involved:	As	mentioned	above,	sources	include	
the hospital. These can range from canes and walkers to          patients, physicians, and vendors. There can be a long list
ventilators and infusion pumps. Vendors have a variety of        of	vendors.	Divide	them	into	types,	such	as	home	health-
reasons for bringing in their equipment. They may bring          care, manufacturers, rental companies, leasing compa-
in a service loaner, a new model to show to clinical staff,      nies, and medical service providers. You will likely need
or a unit that could be left for days or weeks for a clinical    to deal with different types of vendors differently, but,
trial and evaluation. Leased and rented equipment comes          within types, you can usually deal with them similarly.
and goes as needs fluctuate, when equipment requires             Likewise, divide equipment into types, from simple me-
service, or as contracts change. Physicians can bring in         chanical aids, such as canes and walkers, to life support
their own equipment for special procedures, and medical          devices, such as ventilators and ventricular assist devices,
service companies can have contracts that require them           because you will need to manage different types of equip-
to provide their own equipment, such as a dialysis ma-           ment differently as well.
chine.                                                              Involve representatives from all interested par-
   Valid concerns about non-hospital owned medical               ties: Check with your own clinical engineering staff and
equipment include:                                               with clinical area managers to determine what types of
   •	 Is	it	safe	and	effective?                                  non-hospital owned medical equipment they encounter,
   •	 Does	it	meet	applicable	accreditation	standards?           and to hear their concerns and suggestions for mitigating
   •	 What	is	the	legal	liability?                               risks. Touch base with the purchasing and legal depart-
   •	 How	has	it	been	cared	for	and	maintained?                  ments.	You	want	them	to	be	involved.	Ask	them	to	share	
   •	 How	qualified	is	the	owner	when	it	comes	to	main-          their	 concerns	 and	 suggestions.	 Approach	 the	 safety	
       tenance?                                                  committee (hopefully, you are a member) and ask to lead
   •	 Are	there	any	maintenance	or	service	records?              an	 ad	 hoc	 committee	 that	 will	 write	 a	 draft	 policy.	 Ask	
   To some extent, the management of non-hospital                for “volunteers” for your group and include, at the least,
owned medical equipment depends on the unique char-              representatives from nursing, respiratory therapy, law of-
                                                                 fice,	and	purchasing.
                   Robert H. Stiefel, MS, CCE, is president of      Draft a hospital safety policy: Use your hospital’s
                   RHS Biomedical Consulting LLC. E-mail:        format for safety policies, and submit your draft to the
                                                                 full	safety	committee.	Do	a	quality	job,	but	make	it	clear	
                                                                 that	you	understand	it	is	subject	to	review	and	develop-
                                                                 ment. There will probably be one or two areas where you
                                                                 are not certain what a particular procedure should be.

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      Non-Hospital Owned Medical Equipment Poses Challenge

Highlight	these	and	offer	a	recommendation	or	alterna-
   The draft policy should address:
                                                                     “      You should always be looking for ways to
                                                                           occasionally ‘show face’ with your primary
                                                                              customers—nurses. They should know
   •	 Patient-owned devices                                                        who you are, that you care about
        Simple and safe devices can be allowed after a                          patient care, and, most importantly,
          patient’s nurse or the charge nurse does a physi-                                that you are approachable.
          cal inspection. Such devices include canes, walk-
          ers,	CPAP/BiPAP	masks	(but	not	the	machine),	                         evaluation or on loan (i.e., to be used on patients),
          and TENS units.                                                       the purchasing and legal departments probably
       	 Any	device	for	which	the	hospital	has	an	alterna-                     insist on a no-charge purchase order. This docu-
          tive should be prohibited. Such devices include                       ments ownership and protects both the vendor
          CPAP	and	BiPAP	machines,	ventilators,	infusion	                       and the hospital. The equipment should be in-
          pumps,	wheelchairs,	and	heating	pads.	At	issue	                       spected, which might require assistance from the
          are questions about safe and effective perfor-                        vendor. Most likely, the equipment will be in the
          mance, maintenance and cleaning, and proper                           hospital	briefly,	as	specified	in	the	purchase	or-
          use and operation of critical and potentially dan-                    der, so it is not necessary to add it to the medical
          gerous equipment.                                                     equipment	inventory.	If	the	equipment	is	going	
       	 It’s	probably	worth	mentioning	that	implantable	                      to be in the hospital longer than an inspection
          devices are excluded from this policy.                                cycle for comparable equipment, you should add
       	 It	 might	 also	 be	 worth	 mentioning	 patient-                      it to the inventory, and manage it the same way
          owned,	non-medical	devices.	If	you	have	a	poli-                       as hospital-owned equipment.
          cy,	refer	to	it.	If	you	do	not,	you	could	say	that,	               For equipment that is being brought in for
          in general, items that provide entertainment or                       demonstration purposes only (i.e., no patient
          activity for the patient are allowed if the patient’s                 contact), it is not necessary to inspect it or add it
          nurse or the charge nurse approves and does a                         to the inventory.
          physical inspection.                                          •	 Exceptions require a physician’s order, the approv-
   •	 Physician-provided	 equipment	 should	 be	 treated	                   al of the administrator on-call, and a waiver (with a
       like	 the	 hospital’s	 own	 medical	 equipment:	 De-                 form provided by the legal department) signed by
       cide whether it meets your criteria for inclusion in                 the patient or parent if the patient is a minor.
       the	inventory.	If	so,	inspect	it,	add	it,	and	tag	it	as	         After	the	safety	committee	has	approved	a	draft	policy,	
       usual.                                                        suggest that nursing leadership have a crack at it, too.
   •	 Vendor-owned equipment                                         Their buy-in is critical to the policy’s success. Make this
        For vendors who regularly provide rental equip-             into an opportunity to meet with clinical and support
          ment, visit their facilities to review how they            area leadership, not only to solicit their cooperation, but
          handle inspection, maintenance, and record-                also	 to	 raise	 the	 profile	 of	 your	 department.	 Ask	 to	 get	
          keeping.	If	their	processes	meet	your	standards,	          on the agenda of a nursing administration meeting to
          then you can specify that they have your approval          discuss	the	subject.	
          to bring their equipment into the hospital, and               Keep	your	presentation	short	and	to-the-point.	Hand-
          your clinical engineering department does not              outs, such as an outline of your presentation, always help.
          have	 to	 reinspect	 it.	 If	 they	 do	 not	 meet	 your	   You	could	introduce	the	subject	by	relating	one	or	two	
          standards,	 you	 should	 ask	 them	 to	 comply.	 If	       instances when patient-owned equipment has presented
          they	do	not,	you	should	find	an	alternate	source	          a problem, whether it was confusion over inspecting or
          that does.                                                 operating a device, a malfunction, or interference with
        For equipment that is leased, you should decide             other equipment. You should point out that The Joint
          whether it meets your criteria for inclusion in            Commission requires all medical equipment to be as-
          the	medical	equipment	inventory.	If	so,	inspect	           sessed for its inclusion in the inventory, and, based upon
          it, add it to the inventory, and tag it.                   that assessment, may need to be inspected. Provide the
        For equipment that is brought in for clinical               draft policy in order to get feedback. You would like to

416                                                                                                         September/October 2010
                                                                             ACCREDITATION NEWS & VIEWS
                                                                                                                     Robert Stiefel

know what non-hospital owned medical equipment they
have seen, what concerns or problems they have, and
what they think are reasonable steps to assure safe and
effective patient care when they have to deal with non-
hospital owned medical equipment.
    Publicize the new policy:	After	the	safety	commit-
tee, nursing administration, and your hospital’s policy
committee have signed off on the policy, and before it is
implemented, provide a few days of publicity. This should
make sure that anyone who is affected by the policy has
the opportunity to ask any questions. Patient-care staff
are the best people for making sure that non-hospital
medical equipment is managed per the policy; they are            A technician readies a portable dialysis machine. Such equipment can
                                                                 sometimes be on loan from a medical service company.
the	first,	and	sometimes	the	only	people	to	be	aware	of	
its presence. Make sure that you provide a contact name
and number for answering any questions. Use the hos-
pital	intranet	and/or	newsletter	to	distribute	the	policy.	      tion of the nursing staff. Nurses are the ones who will
See	if	you	can	get	some	quotes	from	the	C-Suite.	Heck,	          either be asked by patients whether it is OK for them
you might even delicately suggest that one of them con-          to use their own medical equipment, or observe its use
gratulate you for your effort at improving patient care          if	 (when?)	 patients	 don’t	 ask.	 Nurses	 are	 also	 the	 most	
and patient safety.                                              likely to know about equipment brought in by vendors
    A	more	personal	way	to	publicize	the	policy	is	to	get	       or physicians.
invited to staff meetings in clinical areas. You should al-           Make sure that your clinical engineering staff are very
ways be looking for ways to occasionally “show face” with        familiar	with	the	new	policy.	As	a	team,	you	should	an-
your primary customers—nurses. They should know                  ticipate that there will be questions and issues when the
who you are, that you care about patient care, and, most         policy	is	first	implemented.	One	likely	scenario	is	for	a	
importantly,	that	you	are	approachable.	By	extension,	it	        charge nurse to ask for help or guidance in doing a physi-
is equally important for your own clinical engineering           cal inspection of a patient’s medical equipment. They
staff to be known, to be known for caring, and to be ap-         may wonder how to spot damage, or what kind of damage
proachable. They should be making regular rounds to all          would	preclude	use	by	a	patient.	These	judgments	come	
clinical areas. They, too, can use that as an opportunity to     from experience, and you and your staff have tons of that.
promote this new policy.                                         The bigger trick is to make it obvious that you are more
    Another	 important	 step	 is	 to	 include	 a	 summary	 of	   than	 willing	 to	 help.	 If	 it	 appears	 that	 a	 particular	 area	
the policy in patient information brochures. There may           is struggling with the implementation of the policy, you
not be enough time to get information added before the           should have a meeting with the manager, and offer to
policy is implemented, or, even more likely, the admitting       provide training or guidance.
department may not want to throw out the brochures they               An	area	in	which	you	should	expend	a	little	extra	ef-
already have. Until they can get new brochures printed,          fort is the operating room. No area is more likely to have
you should ask them to insert a form that explains the           vendors or researchers who want to bring in non-hospital
policy to patients.                                              owned	medical	equipment.	Develop	a	strong	working	re-
    Finally, solicit the help of the purchasing department       lationship	with	the	manager.	At	least	initially,	bend	over	
to tell vendors that any equipment they bring in for pa-         backwards to help. Surgeons will take a long time to get
tients must have a purchase order and must be inspected          used to the idea that evaluation and research equipment
by clinical engineering.                                         must be approved prior to use—if they ever do. Until
    Implement the policy:	Well,	the	fun	is	over,	and	the	        then, be prepared to send someone to the operating room
real work begins. You need to ensure that the policy is          on a moment’s notice in order to inspect a new device.
implemented	properly.	As	I	mentioned,	the	biggest	fac-           Eventually, you will work out a system with the surgeons
tor, by far, in the success of this policy is the coopera-       and	nursing	staff	that	satisfies	everyone.	

Biomedical Instrumentation & Technology                                                                                                 417
      Non-Hospital Owned Medical Equipment Poses Challenge

    Monitor its success: Make sure that the policy                 Make adjustments as necessary: If	problems	crop	up	
works. You’ll need to create a way to monitor its perfor-       or	if	modifications	are	recommended,	report	them	to	the	
mance and determine whether there are problems. This            safety	committee,	along	with	your	suggestion.	If	changes	
should not require anything elaborate, but it should be         are made to the policy, provide appropriate notices and
reliable. For example, at your own department meetings,         ensure	 that	 the	 changes	 are	 implemented.	 As	 with	 the	
make sure that you ask your staff to look for non-hospital      initial policy, you should monitor the performance of the
owned medical equipment during clinical-area rounds.            modified	policy	and	make	further	adjustments	as	neces-
For the simple, patient-owned equipment, they should            sary. Such is the nature of performance improvement. n
make sure that it is in good physical condition. For ven-
dor or physician-provided equipment, make sure that
it has been inspected. They should let the charge nurse          What Do You Think?
know about any problems, and then help to resolve them           I	welcome	your	thoughts	on	this	subject.	Have	I	un-
quickly	and	effectively.	If	there	is	a	pattern,	they	need	to	    der-	or	over-emphasized	anything,	or	missed	a	point	
let you know.                                                    entirely?	 Have	 you	 found	 success	 with	 a	 different	
    You should check with clinical areas yourself, too. The      policy	and	procedure?	I	also	want	your	suggestions	for	
best way to do that is via periodic attendance at clinical       other	issues	involving	regulatory	compliance.	Anyone	
area	 staff	 meetings.	 Attending	 these	 meetings	 once	 or	    who submits a topic that is used in this column will get
twice a year is excellent for maintaining customer sat-          an	AAMI	golf	shirt.	What	could	be	more	rewarding?	
isfaction and for discussing particular topics that affect       Send your comments to Sean Loughlin, managing
both	your	department	and	clinical	areas.	Be	receptive	to	        editor of BI&T,
concerns and encourage suggestions for improvement.

                                                           If you manage
                                                           healthcare technology . . .
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418                                                                                                September/October 2010

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